MedTrace Logo

A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)

NCT03412773 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 684

Last updated 2025-10-14

Study results available
· View outcomes & findings →

Summary

This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

DRUG

Tislelizumab

Tislelizumab 200 mg intravenously (IV) once every three weeks (Q3W)

DRUG

Sorafenib

Sorafenib 400 mg orally (PO) twice daily (BID)

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director, MD · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2022-07-11
Completion
2023-12-14
FDA Drug
Yes

Countries

  • United States
  • China
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Poland
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03412773 on ClinicalTrials.gov